Prescription drug · ANDA
Droxidopa NDC 70771-1610
Droxidopa 200 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1610-9 | 7077116100970771161009 | 90 CAPSULE in 1 BOTTLE (70771-1610-9)Marketed from Feb 19, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Droxidopa
- Generic name (nonproprietary)
- droxidopa
- Active ingredients
- Droxidopa — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211818
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 70771-1610_2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6ebSPL ID 2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6ebSPL set ID e9894e44-99ff-471a-bcc2-bfecd55a6559RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0370771160990, 0370771161096, 0370771161195
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771161009followed by a unit qualifier and the quantityPackage 70771-1610-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
About NDC 70771-1610
- What is NDC 70771-1610?
- 70771-1610 is the product NDC for Droxidopa, Droxidopa 200 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Droxidopa.
- What is the active ingredient?
- Droxidopa.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Droxidopa?
- 41 other product NDCs are listed under this name. See all Droxidopa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Droxidopa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | CivicaScript LLC | 82249-551 | 82249-0551-90 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | CivicaScript LLC | 82249-552 | 82249-0552-90 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | CivicaScript LLC | 82249-554 | 82249-0554-90 |
| droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Slate Run Pharmaceuticals, LLC | 70436-140 | 70436-0140-06 |
| droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Slate Run Pharmaceuticals, LLC | 70436-141 | 70436-0141-06 |
| droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Slate Run Pharmaceuticals, LLC | 70436-142 | 70436-0142-06 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-256 | 69452-0256-19 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-257 | 69452-0257-19 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-258 | 69452-0258-19 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-987 | — |
Other NDCs under ANDA 211818
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1389 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1390 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1391 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1609 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1611 |